FDA Proposes E-Cigarette Regulations

The new rules, made public Thursday, would give the FDA the authority to regulate e-cigarettes as tobacco products, placing them under the same requirements as cigarettes. That would include a ban on the sale to minors.

The new proposed regulations would also give the FDA oversight of numerous tobacco products that up to now have had no federal oversight. Those products include cigars, pipe tobacco, nicotine gels and waterpipe (or hookah) tobacco.

"Today, we're taking another very important step toward the goal of a tobacco-free generation," U.S. Health and Human Services Secretary Kathleen Sebelius said during a Thursday afternoon news conference.

"We know the use of novel products like so-called e-cigs is on the rise, particularly among young people," she added. "We don't know yet the full impact and ramification these products have on our nation's health. We don't yet have a full understanding as to whether these products serve as a gateway to the use of regular cigarettes, and we don't know how they influence the behavior of current smokers."

The proposed regulations would require makers of "newly deemed" tobacco products such as e-cigarettes to:

register with the FDA and report product and ingredient listings,

only market new products after an FDA review,

only make claims of reduced health risks if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health,

not distribute free samples.

In addition, the proposal would require minimum age and identification restrictions to prevent sales to underage children; require health warnings; and prohibit sales through vending machines, unless they're in a facility that never admits children.

"Tobacco remains the leading cause of death and disease in this country," FDA Commissioner Dr. Margaret Hamburg said in an agency news release. "This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products. Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth."

The FDA is basing its proposed regulations on the Family Smoking Prevention and Tobacco Control Act, which was signed by President Barack Obama in 2009 and gave the agency oversight of tobacco products.

The FDA said the public, the electronic cigarette industry and others will have 75 days to comment on the proposed regulations. Then the agency will review those comments before issuing a final rule.

E-cigarettes are battery-operated devices that turn nicotine, flavorings and other chemicals into a vapor that can be inhaled. Most are designed to look like a tobacco cigarette, but some look like pens, USB drives or other everyday objects.

The devices are advertised on TV and the Internet, and come in sweet flavors like green apple, watermelon and bubble gum.

Erika Sward, the American Lung Association's assistant vice president for national advocacy, applauded the FDA's proposal.

"It would give FDA authority over all unregulated tobacco products," she said. "That would be e-cigarettes, but it also would be cigars, little cigars, hookah-type tobacco and any other products that aren't currently under the FDA's authority now."

Such regulations would close a huge loophole that allows children to freely purchase e-cigarettes and little cigars in many parts of the country, according to proponents of stricter regulations.

E-cigarette use more than doubled among middle and high school students from 2011 to 2012, with more than 1.78 million students nationwide inhaling nicotine-laced vapor from the devices, the U.S. Centers for Disease Control and Prevention reported last year.

"What's concerning is that high rate of rise," said Dr. Hilary Tindle, assistant professor of medicine and director of the tobacco treatment service at the University of Pittsburgh Medical Center. "Who knows where it will be next year, or the year after that? Everyone agrees that's not a good thing. The least amount of regulation has to close that hole, so children can't get access to them as easily."

The drive for regulation is also being fueled by a dramatic increase in the number of calls to poison centers involving nicotine poisonings from e-cigarettes, according to federal health officials.

Calls related to poisoning from the liquid nicotine in the devices rose from about one a month in 2010 to 215 in February this year, the CDC reported in April.

Electronic cigarettes may be safer than conventional tobacco cigarettes, in that people don't have to inhale harmful smoke. But without regulation, it's impossible to know what people are inhaling when they use an e-cigarette, Tindle said.

"There are so many manufacturers right now making e-cigarettes, and there have been multiple reports of contaminants in the vapor and in the e-liquids," she said. "People don't necessarily know what they are getting in their bodies, based on the label."

The new regulations would end the "Wild West" nature of the e-cigarette market, Sward said.

"Once these companies come under FDA authority, it would require them to register with the FDA to disclose their products and ingredients. That's really important in understanding how these new products impact public health," she said.

Given the lack of federal action until now, some states and cities have started pursuing e-cigarette regulations of their own. New York City added e-cigarettes to the city's overall ban on smoking in December, treating them the same as tobacco products.

Some argue that e-cigarettes can help people quit smoking, but evidence supporting that claim has been mixed. Recent studies published in The Lancet and JAMA Internal Medicine have reported that e-cigarettes either don't help people quit or are about as effective as a nicotine patch.